Determination of the Iodine Status in Pregnant Women in the Netherlands.

NCT ID: NCT06412744

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2024-05-01

Brief Summary

Study to determine iodine status in dutch pregnant women

Detailed Description

Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.

Conditions

Pregnancy Related; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Total cohort

No intervention, all participants undergo the same measurements

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female
• 18-45y old
• in first 16 weeks of pregnancy
• pregnant of singleton

Exclusion Criteria

• Thyroid-disease or any other metabolic disease
• kidney disease
• twin-pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht UMC+

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL8297

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL70677.068.19

Identifier Type: -

Identifier Source: org_study_id